An Innovative Treatment for Cervical Pre Cancer (CryoPen)

NeuroTherapia, Inc.

Status: Completed

Conditions: Cervical Intraepithelial Neoplasia

Treatments: Device: CO2 standard cryotherapy; Device: CryoPen; Device: Thermocoagulator

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02814448

UH2CA189883 (U.S. NIH Grant/Contract)

15-296

Details and patient eligibility

About

The purpose of this study is to test two innovative devices, the CryoPen® and thermocoagulator, against gas-based cryotherapy to determine whether the novel devices produce equivalent or improved destruction of cervical tissue compared to gas-based cryotherapy. Tissue destruction with single freeze versus double freeze treatments with the CryoPen and gas-based cryotherapy will also be compared.

Full description

The primary objectives of the study are to test the hypothesis that the CryoPen® and thermocoagulator provide a non-inferior depth of cervical tissue necrosis compared with traditional CO2-based cryotherapy and to test single versus double freeze applications. The secondary objectives of the study are to determine if the CryoPen® or thermocoagulator achieves a depth of necrosis of 3.5 mm, the accepted depth required for eradicating 95% of cervical precancer, and to observe the relationship between depth of necrosis and variations in cervical anatomy.

Enrollment: 130 patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Between 25 and 65 years old.
• Scheduled for a hysterectomy for reasons other than cervical precancer or cancer
• Diagnosis of uterine, endometrial, ovarian or other cancer that does not jeopardize the tissue of the cervix is permitted
• Histological evaluation of the cervix does not interfere with the woman's current diagnosis
• Woman consents to participate after being informed about the study
• Normal Pap Smear or HPV test in the past 3 years

Exclusion criteria

• Pregnancy
• History of cervical surgery in past 5 years
• Presence of cervical lesion pre-invasive or invasive on the cervix *
• Current Pelvic Inflammatory Disorder or severe acute cervicitis
• Cervix shape disfigured or hard to reach

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 5 patient groups

CO2 standard cryotherapy- double freeze

Active Comparator group

Description:

Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze

Treatment:

Device: CO2 standard cryotherapy

CO2 standard cryotherapy- single freeze

Active Comparator group

Description:

Single freeze treatment consists of one five-minute freeze

Treatment:

Device: CO2 standard cryotherapy

CryoPen- double freeze

Active Comparator group

Description:

Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze

Treatment:

Device: CryoPen

CryoPen- single freeze

Active Comparator group

Description:

Single freeze treatment consists of one five-minute freeze

Treatment:

Device: CryoPen

Thermocoagulator

Experimental group

Description:

Single heat application at 100 ºC for 40 seconds

Treatment:

Device: Thermocoagulator